FDA.reportPublic FDA data

HERizon Vista Single Use Hysteroscope, Pro

Primary DI
00850033976410
Brand
HERizon Vista Single Use Hysteroscope, Pro
Company
Minerva Surgical, Inc.
Model
SH-03C
Device description
For Use with HERizon Vista ViewPoint Endoscopic Video Image Processor
Published
2026-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIHHysteroscope (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850033976417PackageGS110In Commercial Distribution
00850033976410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003397641710850033976417
00850033976410008500339764108500339764100850033976410

GMDN Terms#

Term, Definition table
TermDefinition
Rigid video hysteroscopeAn electrically-powered endoscope with a rigid inserted portion (which may have a flexible-tip) intended for visual examination and treatment of the cervix canal and uterine cavity (uterus), or for removal of an early or non-viable embryo/foetus upon connection to an abortion suction system. It is inserted through the vagina during hysteroscopy; some types are also intended for insertion into the female urethra during cystoscopy. An image sensor chip at the distal end of the device transmits the video images to a display monitor. It is commonly used to evaluate/treat fibroids (myomas), polyps, or conditions related to the menstrual period (e.g., menorrhagia). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
855-646-7874CustomerService@minervasurgical.com

Regulatory Flags#

DUNS number
829616478
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850033976373HERizon Vista ViewPoint Endoscopic Video Image ProcessorJY-MIP-3000JY-MIP-30002026-04-01
00850033976380HERizon Vista Single Use Hysteroscope, DiagnosticSH-02ASH-02A2026-04-01
00850033976397HERizon Vista Single Use Hysteroscope, Model 2SH-02BSH-02B2026-04-01
00850033976403HERizon Vista Single Use Hysteroscope, PlusSH-04BSH-04B2026-04-01
00850033976359HERizon Disposable Endoscopic Scissors XLJY-JD-17-450-BJY-JD-17-450-B2026-02-13
00850033976342Symphion Operative Hysteroscopy System Prime Controller- RefurbishedFG-PRIME25-RFG-PRIME25-R2026-02-13
10850033976356HERizon Disposable Endoscopic Scissors XLJY-JD-17-450-BJY-JD-17-450-B2026-02-13
00850033976366HERizon Disposable Endoscopic Forceps – Alligator XLJY-CC-450-18-SJY-CC-450-18-S2026-02-12
00850033976335Symphion Operative Hysteroscopy System Prime ControllerFG-PRIME25FG-PRIME252025-10-31
00850033976298HERizon Disposable Endoscopic Forceps – Alligator JY-CC-350-18-SJY-CC-350-18-S2024-10-07
00850033976311HERizon Disposable Endoscopic ScissorsJY-JD-17-350-BJY-JD-17-350-B2024-10-07
00850033976267HERizon Disposable Electronic HysteroscopeJY-DEH-001JY-DEH-0012024-10-07
00850033976274HERizon Disposable Endoscopic Forceps - BiopsyJY-PK-350-18-SJY-PK-350-18-S2024-10-07
00850033976281HERizon Disposable Endoscopic Forceps - Foreign Body GrasperJY-C-350-18-SJY-C-350-18-S2024-10-07
00850033976304HERizon Disposable Endoscopic Forceps - Inverted ToothJY-DC-350-18-SJY-DC-350-18-S2024-10-07
00850033976250HERizon Medical Endoscope Image Processor JY-MIP-1000JY-MIP-10002024-10-07
10850033976264HERizon Disposable Electronic HysteroscopeJY-DEH-001JY-DEH-0012024-10-07
10850033976271HERizon Disposable Endoscopic Forceps - BiopsyJY-PK-350-18-SJY-PK-350-18-S2024-10-07
10850033976288HERizon Disposable Endoscopic Forceps - Foreign Body GrasperJY-C-350-18-SJY-C-350-18-S2024-10-07
10850033976295HERizon Disposable Endoscopic Forceps – Alligator JY-CC-350-18-SJY-CC-350-18-S2024-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327616675SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616682SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616699SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616705SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616712SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616729SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616736SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616743SPYSTRYKER CORPORATIONHIH2024-02-27
07613327624311NASTRYKER CORPORATIONHIH2024-02-27
07613327507102N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507119N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507126N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507133N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507140N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
14042761085172OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085189OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085196OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085202OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085219OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085226OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085233OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085240OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085257OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085264OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085271OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085288OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085295OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085301OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085318OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085325OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31